Retrospective multicenter study of elderly patients with platinum-sensitive relapsed ovarian cancer treated with trabectedin and pegylated liposomal doxorubicin (pld) in a real-world setting: a geico study

BMC Cancer. 2024 Jul 5;24(1):803. doi: 10.1186/s12885-024-12577-z.

Abstract

Background: Trabectedin in combination with pegylated liposomal doxorubicin (PLD) is approved for the treatment of patients with platinum-sensitive relapsed ovarian cancer. Nevertheless, there is currently limited information regarding this treatment in elderly patients with ovarian cancer in a real-world setting.

Methods: This observational and multicentric study retrospectively evaluated trabectedin plus PLD in a real-world setting treatment of elderly patients diagnosed with platinum-sensitive relapsed ovarian cancer, treated according to the Summary of Product Characteristics (SmPC) from 15 GEICO-associated hospitals. Patients ≥ 70 years old at the time of treatment initiation and platinum-free intervals ≥ 6 months were considered eligible.

Results: Forty-three patients with a median age of 74.0 years were treated between January 1st, 2015, and December 31st, 2019 in 15 Spanish centers. Four patients achieved complete response (9.3%), 14 (32.6%) partial response, and 13 (30.2%) stable disease as the best radiological response. In the analysis of biological overall response according to CA125 serum levels (i.e., Rustin criteria), 14 responded to the treatment (32.6%), 11 responded and normalized (25.6%), three patients stabilized (7.0%) and three progressed (7.0%). Median progression-free survival (PFS) and overall survival (OS) in the study population were 7.7 and 19.5 months, respectively. The most common grade 3/4 adverse events were neutropenia (n = 8, 18.7%) and asthenia (n = 5, 11.6%).

Conclusions: This analysis demonstrated that trabectedin combined with PLD is a feasible and effective treatment in elderly patients with platinum-sensitive relapsed ovarian cancer, showing an acceptable safety profile, which is crucial in the palliative treatment of these patients.

Keywords: Elderly; Ovarian cancer; Real-world studies; Trabectedin.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols* / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols* / therapeutic use
  • Doxorubicin* / administration & dosage
  • Doxorubicin* / adverse effects
  • Doxorubicin* / analogs & derivatives
  • Doxorubicin* / therapeutic use
  • Female
  • Humans
  • Neoplasm Recurrence, Local* / drug therapy
  • Ovarian Neoplasms* / drug therapy
  • Ovarian Neoplasms* / mortality
  • Ovarian Neoplasms* / pathology
  • Polyethylene Glycols* / administration & dosage
  • Polyethylene Glycols* / adverse effects
  • Polyethylene Glycols* / therapeutic use
  • Retrospective Studies
  • Trabectedin* / administration & dosage
  • Trabectedin* / therapeutic use
  • Treatment Outcome

Substances

  • Trabectedin
  • Doxorubicin
  • liposomal doxorubicin
  • Polyethylene Glycols